Non-surgical laser treatment for a fibrous mass

ABSTRACT

Systems and methods for treating a fibrous mass, which is comprised of a Morton&#39;s neuroma, are disclosed. In one exemplary implementation, a method may comprise identifying a location of the fibrous mass and non-surgically delivering electromagnetic energy to the fibrous mass. Embodiments may include delivering the energy via a Nd:Yag laser at various specified parameters, such as spot size, power/fluence, frequency, duration, pulse characteristics, and/or tissue depth, among others.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of application Ser. No. 15/225,402, filed Aug. 1,2016, published as US2017/0028217A1, now U.S. Pat. No. 10,231,942, whichclaims benefit/priority of U.S. provisional application No. 62/198,787,filed on Jul. 30, 2015, and of U.S. provisional application No.62/297,693, filed on Feb. 19, 2016, all of which are incorporated hereinby reference in entirety.

FIELD

This invention relates to a non-surgical treatment for a fibrous mass,such as Morton's neuroma and plantar fibroma.

BACKGROUND

Perineural fibrosis with axonal degeneration and vascular proliferationof the common digital nerve of the second or third intermetatarsal spaceare often referred to as a Morton's neuroma. It is believed thatfibrosis along with degeneration of the nerve occurs as a result ofmechanical irritation or entrapment between the adjacent metatarsalheads. Pain, tingling and numbness are the most common symptoms. Paincan progress to lifestyle limiting.

Referring now to FIG. 1, Morton's neuroma (also known as Morton neuroma,Morton's metatarsalgia, Morton's neuralgia, plantar neuroma,intermetatarsal neuroma, and interdigital neuroma) is a benign neuromaof an intermetatarsal plantar nerve, most commonly of the second andthird intermetatarsal spaces (between 2nd-3rd and 3rd-4th metatarsalheads).

Prior art treatment has included shoe modification, use of orthoticdevices, corticosterioid injections, alcohol sclerosing injections, andsurgical neurectomy.

A fibroma is a non-cancerous, i.e., benign, fibrous tissue tumor orgrowth, that can occur anywhere in the body. For example, on theplantar, or the bottom surface of the foot, the fibromas are calledplantar fibromas. Unlike plantar warts, which grow on the skin, plantarfibromas grow within the plantar fascia, which is a thickened, fibroussheet of connective tissue that originates from the plantar aspect ofmedial tubercle of the calcaneus and extends to the plantar plates ofthe metatarsophalangeal joints with a function of absorbing shock forthe foot during ambulation. The plantar fascia is one of the mostimportant ligamentous bands that maintain the longitudinal arch of thefoot.

The etiology of plantar fibromas have not been clearly identified, butit is more than likely multifactorial. The typical etiology isrepetitive stress overload to the origin of the plantar fascia, togetherwith other causes, such as weight gain, excessive pronation,occupation-related activity, anatomical variations, altered biomechanics(i.e., gait abnormalities), overexertion, and inadequate foot wear.

Plantar fibromas can develop in one or both feet and the common growthis usually a solitary nodule, though multiple nodules are possible inthe same foot. The mid-arch region of the foot is the most commonlocation for planter fibromas to develop. However, plantar fibromas canappear anywhere along the underside of the foot. They can occur inpeople of any age and gender and will not resolve on their own or becomesmaller without proper treatment.

Prior art treatment can be divided into conservative and surgicalmeasures. Conservative and prior art non-surgical measures can alleviatethe pain of a plantar fibroma, but they will not reduce the mass orprevent the progression of the plantar fibroma. These measures typicallyinclude steroid injections, orthotic devices (i.e., orthopedic shoeinsoles), anti-inflammatory drugs, and physical therapy. Operativemeasures are needed when the above measures fail to improve symptoms ofthe plantar fibroma. However, surgical removal of the plantar fibromarequires outpatient care and may result in a flattening of the arch ordevelopment of hammertoes. Recurrence of the plantar fibroma occurs evenafter surgical measures.

SUMMARY

Embodiments of applicant's disclosure describe a method for treating afibrous mass, which comprises a Morton's neuroma or a plantar fibroma.The method comprises identifying a location of the fibrous mass,determining a first size of the fibrous mass, non-surgically deliveringelectromagnetic energy to the fibrous mass, and determining a secondsize of the fibrous mass. The method further comprises determining anumber of a plurality of treatments. In some embodiments, when treatingthe Morton's neuroma, the method further comprising manipulating theMorton's neuroma into a position adjacent a surface of the patient'sfoot.

In certain embodiments, medical imaging techniques, such as ultrasoundimaging and magnetic resonance imaging, are used to identify thelocation of the fibrous mass and to determine the first size of thefibrous mass. In other embodiments, identifying the location of thefibrous mass further includes placing a patient in a supine position,palpating the patient's skin over a suspected location of the fibrousmass, and detecting an audible click when palpating skin directly overthe fibrous mass.

In certain embodiments, the delivering electromagnetic energy to thefibrous mass step further comprises emitting electromagnetic energy froma lasing device in about a 5 mm diameter beam, adjusting a power of tothe lasing device such that the electromagnetic energy penetratestissues to a depth of about 6 mm to about 8 mm, directing the 5 mm beamonto the location for a length of time between about 10 minutes to about5 minutes, and delivering about 1,000 pulses of the 5 mm beam to thelocation. In some embodiments, a Nd:YAG lasing device can be utilized.

In certain embodiments, a topical medication is applied directly on thekin of the location of the fibrous mass. The topical medication isselected from a group consisting of cream, gel, ointment, and lotion. Insome embodiments, the applying the topical medication step furthercomprises using about 15% verapamil by weight, about 3% pentoxifyllineby weight, and about 1% tranilast by weight. In other embodiments, theapplying the topical medication step further comprises using about 15%verapamil by volume, about 3% pentoxifylline by volume, and about 1%tranilast by volume.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be better understood from a reading of the followingdetailed description taken in conjunction with the drawings in whichlike reference designators are used to designate like elements, and inwhich:

FIG. 1 illustrates the anatomy of the medial plantar nerve and thelateral plantar nerve;

FIG. 2 is a flowchart summarizing the steps of Applicant's method fortreating Morton's neuroma;

FIG. 3 illustrates the anatomy of the plantar fascia and the plantarfibroma;

FIG. 4 is a flowchart summarizing the steps of Applicant's method fortreating plantar fibroma;

FIG. 5A is an ultrasound image showing a plantar fibroma before thelaser treatment; and

FIG. 5B is an ultrasound image showing the plantar fibroma that isreduced in size after the laser treatment,

DETAILED DESCRIPTION

This invention is described in preferred embodiments in the followingdescription with reference to the Figures, in which like numbersrepresent the same or similar elements. Reference throughout thisspecification to “one embodiment,” “an embodiment.” or similar languagemeans that a particular feature, structure, or characteristic describedin connection with the embodiment is included in at least one embodimentof the present invention. Thus, appearances of the phrases “in oneembodiment,” “in an embodiment,” and similar language throughout thisspecification may, but do not necessarily, all refer to the sameembodiment.

The described features, structures, or characteristics of the inventionmay be combined in any suitable manner in one or more embodiments. Inthe following description, numerous specific details are recited toprovide a thorough understanding of embodiments of the invention. Oneskilled in the relevant art will recognize, however, that the inventionmay be practiced without one or more of the specific details, or withother methods, components, materials, and so forth. In other instances,well-known structures, materials, or operations are not shown ordescribed in detail to avoid obscuring aspects of the invention.

Referring now to FIG. 1, perineural fibrosis of the common digital nerveof the second or third intermetatarsal space is often referred to as aMorton's neuroma. It is believed that fibrosis along with degenerationof the nerve occurs as a result of mechanical irritation or entrapmentbetween the adjacent metatarsal heads. Pain, tingling and numbness arethe most common symptoms. Pain can progress to lifestyle limiting.

Applicant has found that Morton's neuroma can be effectively treatedusing non-surgical treatments of laser energy. Surgery is a technologyconsisting of a physical intervention on tissues, and muscle. As ageneral rule, a procedure is considered surgical when it involvescutting of a patient's tissues or closure of a previously sustainedwound. Applicant's method to treat Morton's neuroma neither involvescutting of a patient's tissues, nor closure of a previously sustainedwound.

Other procedures, such as angioplasty or endoscopy, may be consideredsurgery if they involve “common” surgical procedure or settings, such asuse of a sterile environment, anesthesia, antiseptic conditions, typicalsurgical instruments, and suturing or stapling. Applicant's method totreat Morton's neuroma does not require a sterile environment,anesthesia, antiseptic conditions, surgical instruments, suturing, orstapling.

FIG. 2 summarizes the steps of Applicant's method for treating Morton'sneuroma. Referring now to FIG. 2, in step 205 the method verifies thepresence of a Morton's neuroma using one or more medical imagingtechniques. Such medical imaging techniques include, without limitationmagnetic resonance imaging (“MRI”) and/or ultrasound imaging.

In certain embodiments, the target area of the neuroma is identifiedusing Applicant's “Dull Probe Technique,” wherein that techniqueincludes using a dull probe while patient is in the supine position,palpating the intermetatarsal space to elicit pain consistent with theirchief complaint and/or a positive Mulder's sign (an audible click). Adiagnostic ultrasound is also used to identify the specific location ofthe neuroma. The target area is marked on the plantar surface of foot toguide laser treatment.

In step 210, and based upon the medical imaging of step 210, set ananticipated number of weekly, non-surgical laser treatments. In step220, the method sets a variable (i) to 1.

In step 230, the method manipulates the verified Morton's neuroma into aposition adjacent to a surface of the patient's foot. In step 240, themethod positions a lasing device such that output power emitted by thatlasing device is directed onto the surface of the patient's footdirectly over the plantar surface of the Morton's neuroma.

In certain embodiments, step 230 further comprises applying a topicalmedication to the surface of the foot directly over top of the Morton'sneuroma. Applicant's topical medication is made by a compoundingpharmacy and comprises Verapamil 15%, Pentoxifylline 3% and Tranilast1%. The medication is applied just prior to the laser treatment and isallowed to absorb.

Applicant's topical medication is used to treat fibrotic conditions,like plantar fibromas and Dupuytren contracture and scarring. Applicanthas found that use of this topical medication assists treatment of thefibrosis around the nerve when used with the Nd:YAG laser.

In certain embodiments, the lasing device of step 240 comprises a Nd:YAGlaser.

In step 250, the method configures the lasing device of step 240 to emitelectromagnetic energy in a beam of a about 5 mm spot size diameter. Instep 260, the method configures the lasing device such thatelectromagnetic energy emitted by that lasing device penetrates tissuesof the foot to a depth of between 6 mm and 8 mm. Applicant hasdemonstrated with magnetic resonance imaging that this tissue depth issufficient to reach the candidate nerve.

In step 270, the method energizes the lasing device for between about 10to about 15 minutes. In step 280 in certain embodiments, the methodnon-surgically delivers about 1,000 pulses of electromagnetic energy at15 J/cm², 6 msec and 7 Hz to the Morton's neuroma. Step 180 does notinclude cutting of the patient's skin. More specifically, step 180 doesnot include cutting the patient's skin disposed over or adjacent to thepalpated Morton's neuroma. Step 180 does not include closure of apreviously sustained wound.

In step 280 in certain embodiments, the method non-surgically deliversabout 1,000 pulses of electromagnetic energy to the Morton's neuroma.

In step 290, the method determines if (i) equals (N). If the methoddetermines in step 290, that (i) does not equal (N), then the methodtransitions from step 290 to step 292 wherein the method increments (i)by 1, i.e. sets (i) equal to (i+1), The method then transitions fromstep 292 to step 230 and continues as described herein.

If the method determines in step 290, that (i) does equal (N), then themethod transitions from step 290 to step 295 wherein the method reimagesthe Morton's neuroma.

Referring now to FIG. 3, a fibrous knot or nodule that is embeddedwithin the planter fascia is often referred to as a plantar fibroma.More invasive, rapid-growing fibromas are considered plantarfibromatosis. The characteristic sign of a plantar fibroma is anoticeable lump in the arch or instep, between the heel pad and theforefoot pad. The typical plantar fibroma appears as a focal, oftenoval-shaped area with disorganization within the plantar fascia. Largerlesions may be lobulated and can demonstrate a central scar-likeappearance with fibers radiating from the plantar fascia. The mass willcause a soft convexity in the contour of the bottom of the foot that maybe painful with pressure. Also, prolonged walking and wearing shoes cancause pain or discomfort. In some cases, the mass of the plantar fibromacan progress to cause pain to limit patients' lifestyles.

Applicant has found that plantar fibromas can be effectively treatedusing non-surgical treatments of laser energy. Surgery is a technologyconsisting of a physical intervention on tissues, and muscle. As ageneral rule, a procedure is considered surgical when it involvescutting of a patient's tissues or closure of a previously sustainedwound. Applicant's method to treat plantar fibromas neither involvescutting of a patient's tissues, nor closure of a previously sustainedwound.

Other procedures, such as angioplasty or endoscopy, may be consideredsurgery if they involve “common” surgical procedure or settings, such asuse of a sterile environment, anesthesia, antiseptic conditions, typicalsurgical instruments, and suturing or stapling. Applicant's method totreat plantar fibromas does not require a sterile environment,anesthesia, antiseptic conditions, surgical instruments, suturing, orstapling.

FIG. 4 summarizes the steps of Applicant's method for treating plantarfibroma. Referring now to FIG. 4, in step 405 the method verifies thepresence of a plantar fibroma using one or more medical imagingtechniques. Such medical imaging techniques include, without limitation,magnetic resonance imaging (“MM”) and/or ultrasound imaging.

In certain embodiments, the target area of the fibroma is identifiedusing Applicant's “Dull Probe Technique,” wherein that techniqueincludes using a dull probe while patient is in the supine position,palpating the arches of the foot to elicit pain consistent with his/herchief complaint. A diagnostic ultrasound is also used to identify thespecific location of the fibroma. The target area (including size,shape, and boarders of the plantar fibroma) is marked on the plantarsurfaces and/or the arches of foot to guide laser treatment.

In step 410, and based upon the medical imaging of step 410, the methodsets an anticipated number of weekly, non-surgical laser treatments. Instep 420, the method sets a variable (i) to 1. In certain embodiments,the anticipated number of weekly, non-surgical laser treatments equalsto 10.

In step 430, the method manipulates the verified plantar fibroma into aposition adjacent to a surface and/or a bottom of the patient's foot. Instep 440, the method positions a lasing device such that output poweremitted by that lasing device is directed onto the surface of thepatient's foot directly over the plantar fibroma.

In certain embodiments, step 430 further comprises applying a topicalmedication to the area of the foot directly over top of the plantarfibroma. Applicant's topical medication, which can be made in the formof cream, gel, ointment, and lotion, is made by a compounding pharmacy.The topical medication in the form of cream comprises Verapamil 15% byweight, Pentoxifylline 3% by weight, and Tranilast 1% by weight. Inother embodiments, the topical medication in the form of lotioncomprises Verapamil 15% by volume, Pentoxifylline 3% by volume, andTranilast 1% by volume. The medication is applied just prior to thelaser treatment and is allowed to absorb.

Applicant's topical medication is used to treat fibrotic conditions,like plantar fibromas, Dupuytren contracture, and scar tissues.Applicant has found that use of this topical medication assiststreatment of the fibrosis around the plantar fascia when used with theNd:YAG laser.

In certain embodiments, the lasing device of step 440 comprises a Nd:YAGlaser.

In step 450, the method configures the lasing device of step 440 to emitelectromagnetic energy in a beam comprising a about 5 mm spot sizediameter. In step 460, the method configures the lasing device such thatelectromagnetic energy emitted by that lasing device penetrates tissuesof the foot to a depth of between 6 mm and 8 mm. Applicant hasdemonstrated with magnetic resonance imaging that this tissue depth issufficient to reach the candidate plantar fibromas. A sonography studyhas shown that most plantar fibromas (nodules) are located superficiallyin the plantar fascia.

In step 470, the method energizes the lasing device for between about 10to about 15 minutes. In step 480, in certain embodiments, the methodnon-surgically delivers about 2,000 pulses of electromagnetic energy at15 J/cm², 6 msec and 7 Hz to the plantar fibroma. Step 480 does notinclude cutting of the patient's skin. More specifically, step 480 doesnot include cutting the patient's skin disposed over or adjacent to theplantar fibroma. Step 480 does not include closure of a previouslysustained wound.

In step 490, the method determines if (i) equals (N). If the methoddetermines in step 490, that (i) does not equal (N), then the methodtransitions from step 490 to step 492 wherein the method increments (i)by 1, i.e. sets (i) equal to (i+1), The method then transitions fromstep 492 to step 430 and continues as described herein.

If the method determines in step 490, that (i) does equal (N), then themethod transitions from step 490 to step 495 wherein the method reimagesthe plantar fibroma.

The following examples are presented to further illustrate to personsskilled in the art how to make and use the invention. These examples arenot intended as a limitation, however, upon the scope of the invention.

EXAMPLE 1

This Example 1 comprises an unsolicited testimonial from a patient ofApplicant. “My Morton's Neuroma symptoms started a few years ago,beginning with bent toes and a tingling, burning sensation on the bottomof my right foot. Dr. Bocian treated me initially with cortisoneinjections, which worked well for about a year each. Then the symptomsintensified and I felt like I was walking on a marble. Over a fewmonths' time, I was limping badly, causing pain in the left knee andleg. I started actually calculating how many steps I could avoid indaily activities.”

In Oct., I saw Dr. Bocian and asked what we could do short of surgery soI could recover quality of life and normalcy of movement. He told meabout his laser treatment and I began the course of 10 immediately.After treatment no. 2, I felt 95% better.

I feel privileged to have been in Dr. Bocian 's care and offered his newapplication of laser technology for Morton's neuroma.”

EXAMPLE 2

History: 58-year-old female with bilateral feet Morton's neuroma statuspost laser therapy for follow-up.

Comparison: Ultrasound of the right and left feet from 02107/2014.Technique: Focused grayscale and power Doppler ultrasound examination ofboth feet with attention to the forefoot was performed for follow-upbilateral Morton's neuromas.

Right foot: Redemonstrated is a round hypoechoic lesion at the plantaraspect of the second intermetatarsal space between the second and 3rdmetatarsal heads has decreased in size and now measures 0.2×0.2×0.2 cm(AP×TR×CC), consistent with a Morton's neuroma. Redemonstrated is asmall fluid-filled lesion at the plantar lateral aspect of the 3rdmetatarsophalangeal joint, measuring 5 mm in length, which is notcontiguous with the Morton's neuroma, and may represent a smalladventitial bursa or a ganglion cyst. There is no additional soft tissueabnormality at the remaining intermetatarsal spaces.

Left foot: Redemonstrated is a round heterogeneously hypoechoic lesionat the plantar aspect of the second intermetatarsal space between thesecond and 3rd metatarsal heads which has decreased in size and nowmeasures 0.3×0.2×0.1 cm (APX TR XCC), consistent with a Morton'sneuroma. Redemonstrated is an additional ill-defined hypoechoic regionat the 3rd intermetatarsal space between the 3rd and 4th metatarsalheads which also has decreased in size and n w measures 0.1×0.1×0.1 cm,which may represent an additional small Morton's neuroma. There are noadditional soft tissue abnormalities at the remaining intermetatarsalspaces.

Impression: Bilateral second intermetatarsal space Morton's neuromas andleft 3rd intermetatarsal space Morton's neuroma which have decreased insize when compared to reference examination.

EXAMPLE 3

Thirty (30) patients underwent a study evaluating the effect of a Nd:YAGlaser in the non-surgical treatment of Morton's neuroma. Baselinediagnostic MRI and/or ultrasound exams were used to confirm the presenceof a neuroma. A series of weekly laser treatments were given usingApplicant's method. Following completion of the treatments, subjectsreturned for a follow-up MRI and/or ultrasound study.

The results yielded an extremely high patient satisfaction rate.Follow-up comparison studies revealed a decrease in the size of theneuroma.

Of 42 patients undergoing Morton's neuroma evaluation by US, 21underwent treatment of a total of 32 Morton' neuromas. Retrospective USreview of the pre-treatment lesion showed heterogeneously, hypoechoicmasses with well-defined borders with associated pain on transducerpressure in 97% (31/32). An associated bursa (3/28) was identified in aminority of cases. Following treatment the lesions remainedheterogeneously hypoechoic but most demonstrated ill-defined borders(23/31) with significantly decreased or absent pain with transducerpressure (29/31). Statistical analysis revealed significant differencesin appearance of pre and post-treatment lesion borders (p<0.0001) andpain with transducer pressure (p<0.0001), as well as the presence of anassociated intermetarsal bursa (p<0.05), which resolved followingtreatment, but not size. Finally, all neuromas were determined to bebetter visualized on US compared to MRI.

Example 3 demonstrates that the use of a Nd:YAG laser in the treatmentof Morton's neuroma comprises an excellent option with satisfactionrates being superior to previous treatments. This procedure eliminatessurgical intervention along with its associated risks and complications.In addition, out of pocket expense for the patient is reduced. Moreover,there is no down time, and therefore, patients may continue to work andenjoy leisure activities such as golfing, cycling and tennis astolerable throughout the series of treatments.

EXAMPLE 4

History: 57-year-old male with left second inter space Morton's neuromastatus post laser therapy. Comparison: Prior left toot ultrasound datedNov. 10, 2014. Technique: Grayscale and Doppler ultrasound roots viewsof the left forefoot were obtained.

Findings: There is redemonstration of hypoechoic lesion within thesecond intermetatarsal space, measuring 0.4×0.4×0.3 cm (AP×TR×CC), whichis slightly decreased in size compared to prior study measuring0.4×0.5×0.3 cm. There is no significant interval change in theechogenicity or echo texture of this lesion. There is no pain withtransducer pressure, which is improved compared to prior study. There isno additional lesion within the remaining interspaces of tile left foot.

Impression: There is redemonstration of hypoechoic lesion within thesecond demonstrates slight interval decrease in size with no pain ontransducer pressure, consistent with successful treatment.

EXAMPLE 5

This Example 5 comprises an unsolicited testimonial from a patient ofApplicant.

“I became a patient of Dr. Bocian and in Apr. 2015 after being referredby my primary care provider. I had been living with pain from a largeplantar fibroma on my right foot for 2 years. The pain had beenincreasing over the prior 6 months, which caused me to change myliftstyle to avoid jogging, standing for extended time and long hikes.Since Feb. 2015, I would awake with painful cramping of the right footin greater toe and would need to spend several minutes stretching beforeI could walk comfortably.

I have had plantar fibroma surgically removed from my left foot twice inyears prior to this occurrence in my right foot. Both times my onlyoptions were to live with it or surgically remove it. I didn't care forthe long painful and troublesome recovery from the surgery so I avoidedgoing back to the doctor for this new fibroma. After Dr. Bocianexplained the option of laser treatment versus surgery, I was stillhesitant about the treatment but I did not want to repeat the surgeryroute of treatment again. So I decided to give laser treatment a try.

The first 3 laser treatments were uncomfortable at times but Natasha(laser technologist) was very quick and skillful at easing the pain.With each further treatment, I noticed that the morning cramping andpain was disappearing and the nodules were getting softer and smaller.By the end of the treatment plan, I was not having any pain ordiscomfort in my right foot. The only time I had discomfort was afterwalking barefoot and stepped on a rock right on the fibroma. It did hurtfor a few moments.

Since finishing the treatment in Jul. 2015 I've not had any pain orcramping of the right foot. My wife and I have gone on long and hardhikes with no discomfort to me. I still have the nodules, but hey aresofter and smaller. I'm very happy that I took this path for treatment.I knew from the outset that Dr. Bocian could not promise the fibromawould go away but the pain and discomfort did. Thank you Dr. Bocian andNatasha.”

EXAMPLE 6

This Example 6 comprises an unsolicited testimonial from a patient ofApplicant.

“I told Dr. Bocian I was experiencing pain on the arch of my left foot.He sent me for a diagnostic ultrasound and explained I had PlantarFibromatosis. He suggested I try a fairly new laser treatment. I electedto follow his advice and get the laser treatment rather than havingsurgery to remove the fibromas.

My foot was so sensitive Dr. Bocian could barely touch it without mejumping out of my chair. Honestly, I was a little skeptical. The firsttreatment was awful and left me in tears. I was not looking forward tothe remaining treatments but knew I had to go through with them due tothe pain I was experiencing and the affect it was having on my qualityof life.

With each treatment, my foot was getting better and there was less andless pain. By the ninth treatment I was 100% better, the laser workedwonderfully and I couldn't be happier. I'm so glad I continued thetreatment each week. Jam back to dancing and getting my quality of lifeback.

When I went back to get my follow-up diagnostic ultrasound at Universityof Arizona Medical Center, the tech remembered me and told me shecouldn't believe the difference. She said when she did my firstultrasound, I would pull my foot away and now she was able to press onmy foot and there was no pain.

I want to thank Dr. Bocian and Natasha for being so patient with me. Mytreatments took longer than normal due to the sensitivity of my foot andthey had to keep stopping. I would recommend this treatment to anyoneexperiencing Plantar Fibromatosis and to not get discouraged after thefirst treatment! It gets better! Thank you again!”

EXAMPLE 7

This Example 7 comprises an unsolicited testimonial from a patient ofApplicant.

“I'm a nurse who works long 12 hour shifts. I began having pain in thearch and heel of my right foot a year and a half ago. As time went on,the pain got increasingly worse. The pain began affecting my daily life.I had spent hundreds of dollars on shoes, pain creams, and over thecounter orthotics with no help. I finally went to see Dr. Bocian and wasgiven all options from orthotics, laser, and surgery. Surgery was not anoption for me due to cost and down time. I opted for the customorthotics and laser. The price was much more affordable and no downtime! I will admit that I was a little skeptical about the laser atfirst, but I trusted in Dr. Bocian that this will work. By the time mytreatment coarse came to an end, I was amazed how well the laser worked!I am now back to doing the things in life that I had stopped doingbecause of the foot pain. I owe Dr. Bocian and his laser technicianNatasha a huge thank you!”

EXAMPLE 8

This Examples 8 comprises an unsolicited testimonial from a patient ofApplicant.

“I am extremely happy with my laser treatment given by Dr. Bocian andNatasha, his assistant, for my painful plantar fibroma. They are bothvery skilled in using the laser and it is a very good option for thispainful condition.

It took away the discomfort and caused it to shrink away to almostnothing. I am back to walking and jogging and was able to do 6.6 mileswith no problem. Thanks again! I highly recommend Dr. Bocian's lasertreatment for Plantar Fibroma.”

EXAMPLE 9

This Example 9 comprises an unsolicited testimonial from a patient ofApplicant.

“Last July I limped into your office with a lump on the sole of my footand in severe pain. You diagnosed the lump as plantar fibroma. I had atrip to Yellowstone planned in 4 weeks, so you immediately started me ona series of laser treatments. The fibroma improved sufficiently in 4weeks, so that I was able to enjoy my trip.

Today, after 13 laser treatments, I am back to all my normal activitieswhich includes walking for exercise. I would definitely recommend lasertreatment for anyone suffering from plantar fibroma.”

While the preferred embodiments of the present invention have beenillustrated in detail, it should be apparent that modifications andadaptations to those embodiments may occur to one skilled in the artwithout departing from the scope of the present invention.

The invention claimed is:
 1. A method for treating a fibrous masscomprised of Morton's neuroma in a human foot, the method comprising:identifying a location of the fibrous mass in the foot using a medicalimaging technique; determining a size of the fibrous mass located;non-surgically delivering electromagnetic energy from a lasing devicecomprising a Nd:Yag laser to the located fibrous mass during a treatmentof a plurality of treatments of the foot, each treatment including:applying a topical medication directly on a skin surface at a locationwhere each treatment of the located fibrous mass is being administered,wherein the topical medication comprises two or more of verapamil,pentoxifylline, and/or tranilast; emitting electromagnetic energy from alasing device in a beam having a frequency of 7 Hz; directing the beamof the laser over a 5 mm diameter spot on a skin surface of the footsuch that the beam irradiates the location of the fibrous mass;adjusting a power of the lasing device up to 15 J/cm²; delivering atleast 1,000 pulses of the laser to the location, per treatment; anddirecting the beam onto the location to irradiate the fibrous mass for10 minutes; performing 9 of the treatments, and thereby reducing a sizeof the fibrous mass and softening the fibrous mass to an extent suchthat the patient is relieved of disability resulting from the Morton'sneuroma beyond mere reduction in a pain level-associated with thefibrous mass.
 2. The method of claim 1 wherein using the medical imagingtechniques further comprises using magnetic resonance imaging.
 3. Themethod of claim 1 wherein using the medical imaging techniques furthercomprises use of ultrasound imaging.
 4. The method of claim 1, furthercomprising: directing the beam onto the location for 15 minutes.
 5. Themethod of claim 1, wherein each of the pulses has an energy of 15 Jcm²across an area impinged by the laser beam.
 6. The method of claim 1,wherein each of the pulses is applied for a time period of about 6milliseconds.
 7. The method of claim 1, further comprising: deliveringat least 1,500 pulses of the laser to the location, per treatment. 8.The method of claim 1, wherein an additional treatment is performed suchthat the plurality of treatments comprises 10 treatments.
 9. The methodclaim 1, wherein, as a result of administering the plurality of thetreatments, the size of the fibrous masses is reduced between 33% to66%.
 10. The method of claim 1, further comprising: delivering at least2,000 pulses of the laser to the location, per treatment.
 11. The methodof claim 1, wherein the topical medication comprises about 15% verapamilby weight or volume, about 3% pentoxifylline by weight or volume, andabout 1% tranilast by weight or volume.
 12. The method of claim 1,wherein each of the pulses has an energy of about 15 J/cm².
 13. Themethod of claim 1, wherein the delivering electromagnetic energy to thefibrous mass step further comprises: adjusting a power of the lasingdevice such that the electromagnetic energy penetrates the patient'sflesh to irradiate and thereby soften the fibrous mass at a depth of 6mm to 8 mm.
 14. The method of claim 1, wherein the deliveringelectromagnetic energy to the fibrous mass step further comprises:adjusting a power of to the lasing device such that the electromagneticenergy penetrates tissues to a depth of about 6 mm to about 8 mm. 15.The method of claim 1 wherein, as a result of administering theplurality of the treatments, size of the fibrous mass is reduced atleast 33% in measure in at least one dimension, as determined viacomparison of a first image of the fibrous mass obtained via the medicalimaging technique before the plurality of treatments are administeredand a second image of the fibrous mass taken via the medical imagingtechnique after the plurality of treatments are administered.
 16. Themethod of claim 1 wherein the laser comprises a Nd:YAG lasing devicethat delivers laser energy having a power density of about 15 J/cm² orless than 15 J/cm² that is characterized as being less than a fluence atwhich pre-cooling of the treatment area is utilized in association witheach treatment of the plurality of treatments to maintain patientcomfort.
 17. A method for treating a fibrous mass comprised of Morton'sNeuroma in a human foot, the method comprising: identifying a locationof the fibrous mass in the foot; non-surgically deliveringelectromagnetic energy from a lasing device comprising a Nd:Yag laser tothe located fibrous mass during a treatment of a plurality of treatmentsof the foot, each treatment including: directing a beam of the laserhaving a frequency of 7 Hz over a 5 mm diameter spot on a skin surfaceof the foot such that the beam irradiates the location of the fibrousmass; adjusting a power of the laser such that the beam has an energy ofup to 15 J/cm² across an area of the skin surface impinged by the beamduring irradiation of the fibrous mass; delivering at least 1,000 pulsesof the laser to the location, per treatment; directing the beam onto thelocation to irradiate the fibrous mass for 10 minutes; performing 9 ormore of the treatments, and thereby reducing a size of the fibrous massand softening the fibrous mass to an extent such that the patient isrelieved of disability resulting from the Morton's neuroma beyond merereduction in a pain level-associated with the fibrous mass.
 18. A methodfor treating a fibrous mass comprised of Morton's Neuroma in a humanfoot, the method comprising: identifying a location of the fibrous massin the foot; determining a size of the fibrous mass via a medicalimaging technique; non-surgically delivering electromagnetic energy froma lasing device comprising a Nd:Yag laser to the located fibrous massduring a plurality of treatments to the fibrous mass, each treatment ofthe plurality of treatments including: directing a beam of the laserhaving a frequency of about 7 Hz over a 5 mm diameter spot on a skinsurface of the foot such that the beam irradiates the location of thefibrous mass; adjusting a power of the laser such that the beam has anenergy of up to 15 J/cm² across an area of the skin surface impinged bythe beam during irradiation of the fibrous mass, such that theelectromagnetic energy penetrates tissue of the foot to a depth of about6 mm to about 8 mm; and directing the beam onto the location toirradiate the fibrous mass for 10 minutes; performing a plurality of thetreatments, and thereby reducing a size of the fibrous mass andsoftening the fibrous mass to an extent such that the patient isrelieved of disability resulting from the Morton's neuroma beyond merereduction in a pain level-associated with the fibrous mass.
 19. Themethod of claim 18 wherein, as a result of administering the pluralityof the treatments, the size of the fibrous mass is reduced at least 33%in measure in at least one dimension, as determined via comparison of afirst image of the fibrous mass obtained via the medical imagingtechnique before the plurality of treatments are administered and asecond image of the fibrous mass taken via the medical imaging techniqueafter the plurality of treatments are administered.
 20. The method ofclaim 18 wherein each said treatment further includes: applying atopical medication directly on a skin surface at a location where eachtreatment of the located fibrous mass is being administered, wherein thetopical medication comprises two or more of verapamil, pentoxifylline,and/or tranilast.
 21. The method of claim 20, wherein the topicalmedication comprises two or more of: about 15% verapamil by weight orvolume, about 3% pentoxifylline by weight or volume, and about 1%tranilast by weight or volume.
 22. The method of claim 18, wherein theplurality of treatments comprises 9 treatments.
 23. The method of anyone of claim 18, 19, 20, 21, or 22, wherein each of the pulses has anenergy of about 15 J/cm² across an area impinged by the laser beam. 24.The method of claim 23 wherein using the medical imaging techniquesfurther comprises using magnetic resonance imaging.
 25. The method ofclaim 23 wherein using the medical imaging techniques further comprisesusing ultrasound imaging.
 26. The method of claim 23, furthercomprising: directing the beam onto the location for 15 minutes.
 27. Themethod of claim 23, further comprising: delivering at least 1,500 pulsesof the laser to the location, per treatment.
 28. The method of claim 23,further comprising: delivering at least 2,000 pulses of the laser to thelocation, per treatment.
 29. The method claim 23, wherein, as a resultof administering the plurality of the treatments, the size of thefibrous masses is reduced between 33% to 66%.
 30. The method of claim 23wherein the laser comprises a Nd:YAG lasing device that delivers laserenergy having a power density of less than about 15 J/cm², which is afluence level below which pre-cooling of the skin surface of the foot isnot required to maintain patient comfort.